LUNG FLUTE

K060439 · Medical Acoustics, LLC · BYI · Jun 22, 2006 · Anesthesiology

Device Facts

• Record ID: K060439
• Device Name: LUNG FLUTE
• Applicant: Medical Acoustics, LLC
• Product Code: BYI · Anesthesiology
• Decision Date: Jun 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5665
• Device Class: Class 2

Intended Use

The Lung Flute® is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.

Device Story

Lung Flute is a hand-held, self-powered device shaped like a pipe/flute; contains Mylar reed within a hardened plastic tube. Patient exhales through mouthpiece; reed oscillates to produce low-frequency sound waves. Sound frequency approximates resonance frequency of pulmonary secretions; vibrates airways and lungs to thin and mobilize mucus for expectoration. Used to facilitate sputum collection for laboratory/pathologic analysis. Device operates without external power; patient-operated.

Clinical Evidence

Clinical study compared Lung Flute to nebulized hypertonic saline in chronic bronchitis patients. Analyzed biomarkers: Neutrophils, Macrophages, Squamous Cells, Interleukin-8, Fibrinogen, and Elastase. Wilcoxon signed rank test (p<0.05) showed no significant difference in biomarker concentrations between the two methods; both were significantly different from saliva. Results indicate Lung Flute is effective for collecting lower respiratory tract samples.

Technological Characteristics

Hand-held, self-powered acoustic device. Materials: hardened plastic tube, Mylar reed. Principle: acoustic impedance/vibration via reed oscillation. Dimensions: pipe/flute form factor. No external energy source. Non-electronic.

Indications for Use

Indicated for patients requiring sputum collection for laboratory analysis and pathologic examination.

Regulatory Classification

Identification

A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.

Predicate Devices

• Sputum induction by nebulized hypertonic saline (Pre-amendment Device)

Submission Summary (Full Text)

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K06 0439

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## 510(k) SUMMARY 5.0

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| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. § 807.92(c). |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Medical Acoustics LLC |
| Contact Person | Name: Nicolaas J. Smit PhD, VP Science and Technology<br>Address: 255 Great Arrow Ave., Suite 23, Buffalo, NY 14207<br>Phone: [phone]or [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | February 10, 2006 |
| Name | LUNG FLUTE™ |
| Classification Names | Powered Percussor |
| Device Classification | Classification: Class II<br>Classification Panels: Anesthesiology<br>Regulation Number: 868.5665 |
| Predicate Device(s) | Sputum induction by nebulized hypertonic saline. Pre-amendment<br>Device |

Annual program and the program and the comments of

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| Performance<br>Standards | Performance standards have not been established by the FDA under<br>section 514 of the Federal, Food, Drug and Cosmetic Act. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The LUNG FLUTE™ is shaped like a pipe or flute with a plastic<br>mouthpiece at one end. A Mylar reed is attached inside a square hardened<br>plastic tube that flairs on the end to increase the internal air mass, which<br>provides acoustical impedance. When the patient exhales through the "flute-<br>like" device, the reed inside the tube oscillates and acts in tandem with the<br>rest of the device and the lung cavity itself to produce a sound frequency<br>that approximates the resonance frequency of pulmonary secretions. The<br>LUNG FLUTE™ facilitates mucus clearing by generating and delivering a<br>specific low frequency sound that vibrates the airways and lung secretions,<br>causing lung secretions to thin and become expelled. |
| Indications for<br>Use | The LUNG FLUTE™ is indicated for the collection of sputum samples for<br>laboratory analysis and pathologic examination. |
| Technological<br>Characteristics | The LUNG FLUTE™ is a hand-held, self-powered device which facilitates<br>mucus clearing by vibrating the airways. The LUNG FLUTE™ uses sound<br>to vibrate the airways and lungs at a specific frequency. |
| Clinical<br>Performance | A cohort of chronic bronchitis patients underwent sputum induction using<br>the LUNG FLUTE™ and nebulized hypertonic saline. Sputum samples<br>were analyzed for biomarkers indicative of lower respiratory tract samples.<br>Salivary samples were analyzed representing upper respiratory tract<br>samples. The biomarker analyzed were: Neurophil, Macrophages,<br>Squamous Cells, Interleukin-8, Fibrinogen and Elastase. Wilcoxon signed<br>rank test, using a p<0.05, was used to compare concentrations and establish<br>significance.<br><br>The LUNG FLUTE™ and nebulized hypertonic saline produced similar<br>concentrations for Neurophils, Macrophages, Squamous Cells, Interleukin-8<br>and were significantly different from saliva.<br><br>Conclusion: biomarkers found in sputum from samples obtained by<br>nebulized hypertonic saline were similar to those found in sputum samples<br>obtained using the LUNG FLUTE™ |
| Substantial<br>Equivalence | Based on the clinical performance, the LUNG FLUTE™ is substantial<br>equivalent to sputum induction by nebulized hypertonic saline. A pre-<br>amendment device. |

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JUN 2 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nicolaas J. Smit, PhD VP, Science and Technology Medical Acoustics, LLC 255 Great Arrow Avenue, Suite 23 Buffalo, New York 14207

Re: K060439

Trade/Device Name: Lung Flute® Regulation Number: 21 CFR 868.5665 Regulation Name: Powered Percussor Regulatory Class: II Product Code: BYI Dated: June 6, 2006 Received: June 8, 2006

Dear Dr. Smit:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Smit

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice. requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Appendix 1

Indications for Use

510(k) Number (if known): K060439

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Lung Flute® is indicated for the collection of sputum samples for laboratory analysis and pathologic examination.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | |
|------------------------|--|
| (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W. Mah for AAb

(Sign-Off)
mn of Anesthesiology, General Hospital,
con Control, Dental Devices

Number: K 060439

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